CurrentCignaPolicy N/A

Everolimus Products Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for everolimus products (Afinitor, Afinitor Disperz, Torpenz) for Cigna-administered health benefit plans, covering FDA-approved and select other indications.

Policy Summary

PayerCigna

PolicyEverolimus Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revisions (product additions and indication updates)

Effective Date

Next Review DateMar 19, 2025

Key ActionObtain prior authorization and document that patient-specific clinical criteria and prior therapies for the requested everolimus indication are met.

SourceLink

POLICY UPDATE CHANGES

Torpenz (everolimus tablets) was added to the policy with same criteria as the other everolimus products.

Meningioma indication and criteria were removed from 'Other uses with supportive evidence' and later re-added with combination therapy option including bevacizumab.

Uterine sarcoma (PEComa) was added to 'Other uses with supportive evidence' with criteria requiring prior systemic regimen.

Classic Hodgkin lymphoma criteria were changed to require the patient is not a candidate for high-dose therapy and autologous stem cell rescue (and removed prior multi-line requirement).

>=1 yrTypical approval duration

3 brandsProducts covered

15+

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Medical Necessity Criteria

Breast Cancer (FDA-approved)

Approve for 1 year if the patient meets ALL of the following

Breast cancer approval criteria: A) Patient is ≥ 18 years of age; AND B) Patient has recurrent or metastatic, hormone receptor positive (HR+) disease (ER+ and/or PR+); AND C) Patient has HER2-negative breast cancer; AND D) Patient has tried at least one prior endocrine therapy (e.g., anastrozole, letrozole, tamoxifen); AND E) Patient meets ONE of the following: (i) patient is a postmenopausal woman or a man; OR (ii) patient is a pre/perimenopausal woman and meets ONE of: (a) receiving ovarian suppression/ablation with a GnRH agonist; OR (b) has had surgical bilateral oophorectomy or ovarian irradiation; AND F) Patient meets ONE of the following: (i) medication will be used in combination with exemestane and the patient meets ONE of: (a) patient is a man and is receiving a GnRH analog; OR (b) patient is a woman; OR (ii) medication will be used in combination with fulvestrant or tamoxifen; AND G) Patient has not had disease progression while on everolimus.

Neuroendocrine Tumors (FDA-approved)

Approve for 1 year if the patient meets the following

NET approval: Patient is ≥ 18 years of age.

Renal Cell Carcinoma (FDA-approved)

Approve for 1 year if the patient meets ALL of the following

RCC approval: A) Patient is ≥ 18 years of age; AND B) Patient has relapsed or Stage IV disease; AND C) Patient meets ONE of the following: (i) non-clear cell disease; OR (ii) clear cell disease AND the patient has tried at least one prior systemic therapy.

TSC-associated indications (FDA-approved)

Approve for 1 year when criteria met

TSC indications: TSC-associated renal angiomyolipoma: approve for 1 year; OR TSC-associated SEGA: approve for 1 year if therapeutic intervention is required but SEGA cannot be curatively resected.

TSC-associated partial-onset seizures (FDA-approved)

Approve for 1 year if criteria met

TSC seizures: Patient is ≥ 2 years of age for adjunctive treatment of partial-onset seizures.

Other Uses with Supportive Evidence

Approve for 1 year for listed conditions when specified criteria are met

Endometrial carcinoma: A) Patient is ≥ 18 years of age; AND B) The medication will be used in combination with letrozole.

GIST: A) Patient is ≥ 18 years of age; AND B) Patient has tried each of the following: (i) one of imatinib or avapritinib; AND (ii) one of sunitinib or dasatinib; AND (iii) regorafenib; AND (iv) ripretinib; AND C) The medication will be used in combination with imatinib, sunitinib, or regorafenib.

Histiocytic neoplasm: A) Patient is ≥ 18 years of age; AND B) Patient has Langerhans cell histiocytosis, Erdheim-Chester disease, or Rosai-Dorfman disease; AND C) Patient has a PIK3CA mutation.

Classic Hodgkin Lymphoma: A) Patient is ≥ 18 years of age; AND B) Patient has relapsed or refractory disease; AND C) Patient is not a candidate for high-dose therapy and autologous stem cell rescue.

Use of Afinitor, Afinitor Disperz, or Torpenz for indications not listed as FDA-approved or in the policy section “Other Uses with Supportive Evidence” is considered experimental, investigational, or unproven and may be denied. Criteria in this policy govern the covered uses; any requests for unlisted indications will be reviewed against available evidence and the policy will be updated if new published data support additional uses.

Referenced Prior or Concurrent Therapies

Example agent / regimen	Context or indication where referenced	Coverage label
Anastrozole
Referenced as an example of endocrine therapy required prior to everolimus for HR+ breast cancer

Letrozole
Referenced as an example of endocrine therapy required prior to everolimus for HR+ breast cancer

Tamoxifen
Referenced as an example of endocrine therapy required prior to everolimus for HR+ breast cancer

Sunitinib
Listed as an example of prior systemic therapy for renal cell carcinoma and as a therapy option combined in GIST regimens

Sorafenib
Listed as an example of prior systemic therapy for renal cell carcinoma

Axitinib (Inlyta)
Listed as an example of prior systemic therapy for renal cell carcinoma

Lenvatinib (Lenvima)
Listed as an example of prior systemic therapy for renal cell carcinoma

Cabozantinib (Cabometyx)
Listed as an example of prior systemic therapy for renal cell carcinoma

Pembrolizumab (Keytruda)
Listed as an example of prior systemic therapy for renal cell carcinoma

Nivolumab (Opdivo)
Listed as an example of prior systemic therapy for renal cell carcinoma

Pazopanib
Listed as an example of prior systemic therapy for renal cell carcinoma

Imatinib
Required as one option in prior therapy sequence for GIST; also listed among systemic regimens for other hematologic malignancies

Avapritinib (Ayvakit)
Required as one option in prior therapy sequence for GIST

Dasatinib (Sprycel)
Listed as an option (one of sunitinib or dasatinib) in prior therapy sequence for GIST

Regorafenib (Stivarga)
Required in the GIST prior therapy sequence; everolimus considered in combination with imatinib, sunitinib, or regorafenib

Ripretinib (Qinlock)
Required in the GIST prior therapy sequence

Bortezomib
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Bendamustine
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Rituximab
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Cyclophosphamide
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Ibrutinib (Imbruvica)
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Zanubrutinib (Brukinsa)
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Carfilzomib (Kyprolis)
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Ixazomib (Ninlaro)
Example systemic regimen agent listed for Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Authorization, Documentation, and Denial Risk

Prior Authorization

Obtain prior authorization (typical 1‑year approvals)

Prior authorization is recommended/required for everolimus products; approvals are provided for the duration noted in the policy (typically 1 year) when the clinical criteria for the requested FDA-approved indication or other supported indication are met.

Step Therapy

Document required prior therapies before approval

Many indications require prior use of specified therapies before everolimus will be approved; examples include prior endocrine therapy for HR+ breast cancer and prior systemic therapy for clear‑cell renal cell carcinoma, and multiple named kinase inhibitor trials required for GIST.

Breast cancer: tried at least one prior endocrine therapy (e.g., anastrozole, letrozole, tamoxifen) (see breast cancer criteria).
RCC (clear cell): tried at least one prior systemic therapy (see RCC criteria).
GIST: tried imatinib/avapritinib, one of sunitinib/dasatinib, regorafenib, and ripretinib (see GIST criteria).

Covered Products and Codes

Covered productsNDC | product namesCovered

Afinitor	everolimus tablets (Novartis, generic)
Afinitor Disperz	everolimus tablets for oral suspension (Novartis)
Torpenz	everolimus tablets (Upsher-Smith)

Therapy Line Specifications

Varied line-of-therapy rules

Line of therapy notes: Policy specifies prior therapies for several indications: e.g., breast cancer requires prior endocrine therapy; RCC clear cell requires at least one prior systemic therapy; GIST requires multiple prior tyrosine kinase inhibitor regimens; Waldenström requires at least one systemic regimen.

Genomic and Biomarker Preconditions

PIK3CA — biomarker requirement entry

BiomarkerPIK3CA mutation required

IndicationHistiocytic neoplasm (Langerhans cell histiocytosis, Erdheim‑Chester disease, or Rosai‑Dorfman disease)

Age requirementPatient is ≥ 18 years of age

Approval durationApprove for 1 year when criteria met

Policy Definitions and Gender Note

Postmenopausal woman / man (policy gender note)

Policy definitionIn criteria where gender is specified, 'woman' and 'man' are defined by biological traits regardless of gender identity or gender expression.

Usage noteSpecified gender terms in clinical criteria refer to biological sex for purposes such as reproductive status or required interventions (e.g., postmenopausal status, ovarian suppression).

DocumentationWhen criteria reference 'postmenopausal woman' or 'man', clinical documentation should reflect the biological trait relevant to the criterion (e.g., surgical bilateral oophorectomy).

Background and Drug Overview

Everolimus is an mTOR kinase inhibitor marketed as Afinitor, Afinitor Disperz, and Torpenz and is indicated for multiple oncology and tuberous sclerosis complex (TSC)–related conditions. FDA‑approved oncology indications in this policy include treatment of advanced hormone receptor–positive, HER2‑negative breast cancer (in combination with endocrine therapy), select neuroendocrine tumors, and renal cell carcinoma, as well as TSC‑associated manifestations such as renal angiomyolipoma and subependymal giant cell astrocytoma (SEGA). Prior authorization is required and approvals are generally issued for 1 year when the specific clinical criteria for each indication are met.

Policy Updates

2024-07-03addition

Torpenz (everolimus tablets) was added to the policy with the same criteria as the other everolimus products.

2024-03-06annual_revision

Meningioma indication and criteria were added back to 'Other Uses with Supportive Evidence'.

2024-03-06annual_revision

Classic Hodgkin lymphoma criterion requiring at least three prior lines of therapy was added (later modified).